Why Biotech Needs A Next Generation of eTMF Software

In a particularly striking moment at the recent 2024 CDISC TMF EU Interchange in Berlin, I sat surrounded by a room full of experts who have made their careers defining leading strategies in TMF Management. A speaker had just put forth the notion that the supposed advantages of migrating from paper to electronic TMF systems have been largely unrealized; the room was nodding and murmuring their agreement. 

This was not the first time that such a claim was made during the two-day conference, and it wouldn’t be the last; the “failed promises” of eTMF and other software applications indeed emerged as a key theme of the event. 

Despite claims that digitization would enable life science companies to move faster, reduce manual work, and save money, new drugs take longer than ever to get approved, and TMF management has never been more expensive. How could this be? Well, it’s less surprising than you might think. 

The History of eTMF

In the early days of digitizing clinical trials, there weren’t many vendor choices. Reasonably, first movers captured the market; and in a highly regulated industry in which migrations are tough and made tougher by vendors who resist enabling churn, a first choice can stick for a while. 

This means that the eTMF industry has not been particularly well poised for disruption. But the march of progress is relentless, and even a slow-moving industry still moves. It’s time. 

Patterns in Software Innovation

It’s a classic tale in business: the original generation of vendors capture the market early, then lose their dominance due to the emergence of superior products. Veteran professionals may recall the ubiquity of Netscape Navigator in the mid-1990s prior to its eclipse by Microsoft’s innovative Internet Explorer; younger crowds may note how Tesla, an initial EV titan, is now struggling against low-cost competitors selling to buyers who are not attracted by all the bells and whistles. 

This type of market evolution has happened in countless industries including video rental, photography, and personal computers—and always to the consumer’s benefit. In an industry which enables the development of new life-saving treatments, optimizing operations through the adoption of innovative modern solutions can quite literally save lives. 

What’s Wrong With The Status Quo? 

A lot has changed since the first eTMF vendors emerged over ten years ago. The market has matured and expanded, and customers’ priorities have shifted toward a different set of needs.

Early adopters in any market are not necessarily representative of typical customers in an established market, and may have very different priorities—especially when it comes to price and complexity. We see this reflected in eTMF, where a common complaint is that tools initially adopted and shaped by extremely sophisticated enterprise organizations are much too complex for the typical TMF team’s needs; not to mention too expensive. 

The end result of adopting one of these bloated legacy offerings is a team who are frustrated by the presence of superfluous functionality, and ultimately become resistant to using the tool. It’s no surprise that the human element—convincing your team to log in and complete their tasks in a timely manner—remains one of the biggest challenges in eTMF. 

Basic Isn’t Better

Established vendors’ attempts to mitigate this perceived complexity with simplified, entry-level versions of their software may appear compelling; but those efforts remain built atop legacy platforms and mountains of tech debt. As customers mature, they will have a choice: graduate from the beginner offering into a legacy platform mired down by old UI, over-wrought features, and an outdated sense of user flows and business needs, or join a new generation of software vendors on the bleeding edge. 

Better yet, emerging biotechs can avoid that painful migration entirely by choosing a new generation vendor to begin with, who will in turn grow with their customers at a steady pace, as a new generation, cutting-edge system. I have one such vendor in mind.

Responding to the Market: A Next Generation of Software

It’s said that if you build it, they will come. When it comes to Egnyte for Life Sciences, things happened a bit differently—they came, and then we built it. Our industry-agnostic platform attracted life science companies organically for its robust security, governance, and sharing and collaboration tools—features not often seen in your traditional life science software offering. We responded with a formal investment in the space, building our GXP compliant version of the platform in 2020. When life science customers began overwhelmingly storing TMF content in Egnyte, we again responded by developing a purpose-built eTMF solution, released in 2022. That is to say that Egnyte’s MO is to listen to the emerging biotech market and respond, building fresh and modern tools for the needs that exist today among a market that has clearly been historically underserved. 

From simplifying migrations to reducing the number of steps in Quality Control reviews, Egnyte eTMF is here to reduce costs, eliminate complex manual overhead, and get drugs approved faster. The eTMF industry is ready for a change; we’re here to see it through. 

Ready to learn about how Egnyte’s eTMF application is disrupting TMF management? Click here to learn more.

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Leah Weitz

Leah Weitz is a seasoned product expert with over a decade of experience crafting software solutions for highly regulated industries. She began her career designing software for mining and aviation before becoming captivated by the life sciences industry and its potential to preserve and enhance human lives. As a distinguished leader in pharmaceutical and biotech software, Leah has spearheaded the delivery of innovative solutions for biotech manufacturing, promotional material management, and Trial Master File (TMF) management. In her current role as the Senior Product Manager of Life Sciences at Egnyte, Leah applies her extensive industry knowledge to drive the development of the platform’s cutting-edge eTMF software application.

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